GxP Lifeline

Study: Doctors are Ready to Embrace mHealth Tools

More than half a billion smartphone
users are expected to be using mobile health apps this year

Mobile health, or mHealth, has gained significant momentum over the past couple of years, and it will continue to influence product development in 2015. Millennials raised on technology are providing device makers with the unprecedented opportunity to sell directly to consumers in the form of wearable devices and mobile health applications that allow patients and physicians to interact clinically from different locations. The popularity of mHealth tools has been fueled by the growth of the smartphone industry.

More than half a billion smartphone users are expected to be using mobile health apps this year; that number is projected to climb to more than 1.7 billion by 2018.1 Clinicians, who are under pressure to reduce costs and improve outcomes, are in favor of using mHealth tools, as well. Survey results released by the PwC Health Research Institute (HRI) indicate that nearly 90 percent of U.S. clinicians think mobile apps will become essential to patient health management over the next five years.2 Seventy-four percent of the HRI respondents said they would be willing to use data streamed from a mobile app/device to check for ear infection; 53 percent were in favor of using a mobile app/device to analyze urine, and 20 percent have already prescribed nutrition and weight loss apps.3

UK Doctors Have Been Prescribing mHealth Apps Since 2012

The mHealth adoption curve has been slower in the U.S. than in other developed nations. In early 2012, the U.K. Department of Health started encouraging physicians to direct their patients to use mobile apps in an effort to save the National Health Services (NHS) “millions of pounds” in unnecessary doctor visits and to connect people to health services more efficiently.4 mHealth adoption has been so successful in the U.K. that the NHS has created a curated database of government-approved mobile mental health apps on its NHS Choices website. The NHS plans to expand the database to other health areas in the future.5

Generate New Lines of Revenue

Mobile app development is particularly attractive to start-ups, the current market dominators, because apps typically take less time to bring to market and require less, or different, regulatory scrutiny. This is particularly true for apps positioned as wellness devices rather than medical devices. Wellness apps are not regulated, so they allow device makers to expand their product offerings and generate new lines of revenue quickly. However, it can be difficult to determine if a mobile app falls inside or outside the realm of FDA authority, i.e., whether it meets the definition of a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In September 2013, the FDA issued a guidance document, explaining how it intended to regulate the rapid proliferation of mobile health apps. The final guidance, “Mobile Medical Applications: Guidance for Food and Drug Administration Staff,” was issued on February 9, 2015. According the guidance, the “intended use” of the device will determine whether the FDA will regulate it. “When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of the man, the mobile app is a device.”6

Mobile health apps that meet the criteria of a device but pose a low risk to consumers are subject to “enforcement discretion,” meaning the FDA will not enforce requirements under the FD&C Act. Mobile apps that use GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient when near a pre-identified, high-risk location are examples of apps that fall under “enforcement discretion.”7

A current list of examples of regulated apps, apps subject to enforcement discretion and unregulated apps is available at www.fda.gov. Device makers can also email a 513(g) request to the FDA at mobilemedicalapps@fda.hhs.gov, and ask for a formal determination of whether a mobile app falls under regulatory jurisdiction. It takes approximately 60 days to receive a response.

Only Apps That Add “Real Value” Will Attract Investors

Although mobile apps are all the rage, some experts suggest that the mobile health app market may be reaching a tipping point in terms of saturation. They emphasize the need to provide real value, not just novelty or convenience. “Mobile health apps are a hot trend at the moment, but the market is highly saturated, with very few avenues to distribute them,” said Joe Hage, administrator of LinkedIn’s Medical Devices Group, which has more than 275,000 members. “Apps that are simply designed to make life easier aren’t going to get funded. Investors are taking due diligence very seriously. App developers must be able to demonstrate real value.”

FDA Approval Important to Doctors and Patients

With more than 50,000 free and nearly-free app products available, and smartphone real estate relatively sparse, the competition is stiff. Wellness and other nonregulated apps will enter the market faster and at a lower price point, but they may get lost in an overly-saturated market. Apps that add real value are those that provide diagnostic and treatment capabilities, features that will require regulatory approval. Although these apps will take longer to bring to market, regulatory approval may provide a competitive edge, according to the HRI survey. “Twenty percent of respondents acknowledged that FDA approval was very important in their decision to purchase or use a mobile app.8 Similarly, 26% of physicians said FDA approval was most important when deciding to prescribe apps.”9 Successful device and software manufacturers should bear this in mind in 2015.

(7) U.S. Food and Drug Administration, “Examples of Mobile Apps for Which the FDA Will Exercise Enforcement Discretion.” (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368744.htm) Accessed April 2, 2015.

Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.